Zealand Pharma submits Marketing Authorization Application to the European Medicines Agency for glepaglutide in short bowel syndrome

Core Viewpoint - Zealand Pharma has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for glepaglutide, a long-acting GLP-2 analog aimed at treating short bowel syndrome (SBS) in adults [1][2]. Company Overview - Zealand Pharma A/S is a biotechnology company focused on developing innovative peptide-based medicines, with more than 10 drug candidates in clinical development, including two that have reached the market [12][13]. Product Development - Glepaglutide is designed as a liquid product for subcutaneous administration, intended to reduce or eliminate the need for parenteral support in SBS patients [4]. - The MAA submission is based on results from the pivotal Phase 3 trial (EASE-1) and interim results from ongoing long-term extension trials (EASE-2 and EASE-3) [2][3]. Clinical Trial Results - EASE-1 trial involved 106 SBS patients, showing that glepaglutide administered twice weekly significantly reduced weekly parenteral support volume by 5.13 liters compared to 2.85 liters in the placebo group [6]. - In EASE-1, 9 patients treated with glepaglutide achieved enteral autonomy, while no patients in the placebo group were able to discontinue parenteral support [6]. - EASE-2 continues to evaluate the efficacy of glepaglutide, with interim analyses indicating maintained or improved clinical responses [8]. Future Plans - Zealand Pharma plans to initiate the EASE-5 Phase 3 trial in the second half of 2025 to gather further confirmatory safety and efficacy data for regulatory submission in the U.S. [3][11].